Computer Assisted Management of Early Rheumatoid Arthritis-II: Does prednisone inhibit progression of joint damage if early RA is treated very intensively with disease modifying antirheumatic drugs (DMARDs)?
| ISRCTN | ISRCTN70365169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70365169 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/03/2006
- Registration date
- 29/03/2006
- Last edited
- 11/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr A.C.A. Marijnissen
Scientific
Scientific
University Medical Center Utrecht (UMCU)
Department of Rheumatology and Clinical Immunology
F02.127
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2509758 |
|---|---|
| a.c.a.marijnissen@umcutrecht.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Computer Assisted Management of Early Rheumatoid Arthritis-II: Does prednisone inhibit progression of joint damage if early RA is treated very intensively with disease modifying antirheumatic drugs (DMARDs)? |
| Study acronym | CAMERA-II |
| Study hypothesis | Prednisone inhibits progression of joint damage in early RA-patients, even when intensive treatment, according to a strict computer-assisted protocol, is applied. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Rheumatoid arthritis (RA) |
| Intervention | 10 mg of prednisolone daily versus placebo in addition to DMARDs. Two year study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Prednisone and DMARDs |
| Primary outcome measure | Radiologic joint damage of hands and feet according to the van der Heijde modification of the Sharp scoring method. |
| Secondary outcome measures | Number of patients in remission, in which remission is defined as: 1. Number of swollen joints = 0 2. Plus at least two out of three following criteria: 2.a. Number of swollen joints <3 2.b. Erythrocyte sedimentation rate (ESR) <20 mm/1st hour 2.c. Visual analogue scale (VAS) of general well being <20 mm |
| Overall study start date | 01/04/2003 |
| Overall study end date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 220 |
| Participant inclusion criteria | 1. Rheumatoid Arthritis, defined according to the revised American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis 2. A disease duration of less than 1 year, estimated by the rheumatologist 3. Age >18 years 4. No previous treatment with DMARDs or oral glucocorticoids 5. Written informed consent by the patient |
| Participant exclusion criteria | 1. Abnormal renal function (Cockroft <75 ml/min) 2. Abnormal liver function (aspartate aminotransferase [ASAT]/alanine aminotransferase [ALAT] >2 x normal), active or recent hepatitis, cirrhosis 3. Major co-morbidities like malignancies, severe diabetic mellitus, severe infections, severe cardio and/or respiratory diseases 4. Leukopenia and/or thrombocytopenia 5. Inadequate birth control contraception, pregnancy, and/or breastfeeding 6. Treatment with cytoxic or immunosuppressive drugs within a period of 3 months prior to the study 7. Alcohol intake >2 units per day or drug abuse, presently or in the past 8. Psychiatric or mental disorders which makes adherence to the study protocol impossible 9. Taking part in another clinical trial 10. Osteoporotic vertebral fractures |
| Recruitment start date | 01/04/2003 |
| Recruitment end date | 01/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
University Medical Center Utrecht
University/education
University/education
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/nl/ |
|---|---|
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Industry
University Medical Center Utrecht
No information available
Abbott Laboratories
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Abbott, Abbott U.S., Abbott Alkaloidal Company
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/03/2012 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No | |
| Results article | results | 09/09/2020 | 11/09/2020 | Yes | No |
Editorial Notes
11/09/2020: Publication reference added.
